While development of personalized medicines has grown since the human genome was first sequenced in 2001, biopharmaceutical sponsors face a number of hurdles that are impeding more rapid market uptake, according to a recently completed study by the Tufts Center for the Study of Drug Development (CSDD).
Fourteen years after the human genome was initially sequenced, paving the way for development of personalized medicine, 13% of drugs marketed in the U.S. post pharmacogenomic information on the label, but developers continue to encounter challenges relating to basic science, regulatory and reimbursement policies, and, equally critical, clinical adoption, according to Tufts CSDD.
“The biopharmaceutical industry increasingly is committed to translating genomic discoveries into personalized medicines, but it needs to overcome scientific, regulatory, and economic challenges,” said Joshua Cohen, associate professor at Tufts CSDD. “In particular, the continued development of personalized medicine depends on identifying biomarkers and developing clinically useful diagnostic tests.”
He noted, however, that higher R&D success rates alone may not lead translate into commercial success without physicians increasing the rate at which they prescribe personalized medicines, supported by payer willingness to reimburse users.
Other highlights include the following:
To date, the FDA has approved 137 drugs with pharmacogenomics information in their labeling, with 20% of all FDA approvals in 2014 for personalized medicines, according to Tufts CSDD.